1. Field of the Invention
The present invention relates generally to orthopaedic methodologies and apparatus for treating fractures of long bones. More particularly, the present invention relates to methodologies and apparatus for aligning and/or maintaining the reduction of fractures of long bones, to hasten the stimulation of the osteogenesis reaction and the cellular components of fracture healing, and/or to mitigate the pain associated with fractures.
2. Description of the Prior Art
Upon fracturing a long bone such as, for example, the humerus, femur, tibia, radius and ulna, several conventional orthopaedic methodologies are available for treating the fracture.
One such methodology involves closed reduction, application of traction through a tibial traction pin with either suspension of the thigh in a splint or cast. In the case of a fractured humerus, such a method involves closed reduction, and immobilization of the fracture using a plaster splint. This method immobilizes the fracture in long bones during a long healing process.
The above-described orthopaedic method, while widely used, nevertheless suffers from numerous shortcomings and drawbacks. Due to the lack of stability provided by plaster of paris splints or casts, the fracture is not stabilized and thus the patient is typically not free to move the extremity about. As a consequence of not moving the extremity about after such treatment, the patient frequently suffers from bedsores or ulcers, and/or pulmonary emboli. With this method, less than perfect reduction of fracture angulation must be accepted. Also, such a methodology typically results in prolonged time periods for healing of the fracture due to the absence of callus proliferation. Moreover, due to the common paucity of callus formation and frequent non-union rate of fractured femurs treated with conventional traction methods, the patient has suffered an enormous amount in terms of pain, discomfort, and the inability to return quickly to the normal activities of everyday life.
There are other prior art methods of treatment, reduction, and immobilization of fractures in long bones, which have attempted to overcome some of the shortcomings and drawbacks of the above described orthopaedic methodologies.
In particular, U.S. Pat. No. 4,576,153 to Zagorski et al. discloses a prior art orthopaedic method which involves the use of a pre-fabricated humeral brace having estimated corrective-surface contours which are permanently fixed at the time of manufacture. This prior art method involves manipulative closed reduction of a fracture, applying traction forces, and thereafter applying the permanently contoured brace about the fractured limb so as to partially correct the remaining angulation of the fractured fragments after closed reduction and traction forces have been applied.
This method, however, also suffers from numerous shortcomings and drawbacks, as well. In particular, since the corrective surface contour of the brace is preset at the time of manufacture, it usually does not provide the appropriate corrective forces to reduce angulation of the fractured bone fragments of a particular fracture. Also, because the plane in which the angulation of the fracture occurs varies greatly, an infinite number of braces must be available to the orthopaedic surgeon to properly treat a patient using this methodology. Moreover, over time, the angulation of the fractured fragments changes, and thus necessitates application of contour braces having different corrective surface contours to further reduce remaining angulation of the fractured fragments. Also, this prior art contoured brace having permanent estimated corrective surface contours, cannot be adjusted in either degree or position, and thus results in the patient having a fracture which heals with less than optimal reduction. Furthermore, using such prior art humeral contour braces, it is difficult, if not impossible, to make adjustments and/or to correct for slight errors in alignment of the surface contours with respect to the fracture. In addition, with this method of fracture treatment, there are no provisions for stimulating fracture healing.
Along similar principles, U.S. Pat. No. 4,662,364 to Viegas et al. discloses an adjustable brace and method for reducing and immobilizing metacarpal fractures of the hand. As disclosed, by providing appropriate pressure to a metacarpal fracture in a desired location, a reduction of fracture angulation and immobilization of the fractured metacarpal can be achieved while allowing movement of the fingers, wrist and hand. The brace includes (i) a C-shaped bracket having a bite portion formed between two generally flat, parallel elongated members, (ii) an apex pad with a pile surface adjustably coupled to one of the flat elongated members, and (iii) a pair of spaced-apart base pads adjustably connected to the other flat elongated member. The flat elongated members have hook material thereon, whereas the apex and base pads have loop material thereon, so that the apex pad and base pads are configurable at a dihedral angle with the hand insertable between the C-shaped member of the bite portion. As disclosed, this allows the pads to be alignable with respect to the fractured metacarpal. A strap is also provided to clamp together the C-shaped bite portion so as to apply pressure from the pads directly against the fractured metacarpal bones, so as to achieve desired reduction and immobilization of the metacarpal fracture.
This method and brace, while having limited use in treating metacarpal fractures, suffers from numerous shortcomings and drawbacks. In particular, the apparatus used in U.S. Pat. No. 4,662,364 cannot be applied to fractures of long bones such as the humerus or femur, and as with prior art pre-contoured braces described hereinabove, the method disclosed therein is limited to applying in a single plane, three-point fixation of pressure to metacarpal bone fractures, and is incapable of reducing or maintaining an angulated fracture of long bones such as the humerus or femur. Furthermore, since the brace disclosed in U.S. Pat. No. 4,662,364 is limited to applying three-point fixation of pressure (to a fractured bone) in a single plane, the brace cannot be used to reduce an angulated fracture, where the apex of the fracture lies beneath and in the same longitudinal plane as the site of a wound or vital structure such as a major nerve or blood vessel. Also because of the flimsy construction and narrow geometry of the strap, the brace cannot possibly control the alignment of a long bone fracture, resist bending loads in any longitudinal plane, or resist any torsional loads. Moreover, U.S. Pat. No. 4,662,364 does not disclose or suggest a way in which to stimulate healing or osteogenesis (i.e. proliferation of callous), as desired in long bone fractures.
Therefore, it is apparent that there is great need in the orthopaedic art for a novel method and apparatus for aligning fractures in long bones, reducing fracture hemorrhage, accelerating the clotting (cascade) reaction, enhancing the cellular components of fracture healing, and stimulating osteogenesis and relieving fracture pain, while overcoming the shortcomings and drawbacks of prior art methods and apparatus.
Accordingly, it is a primary object of the present invention to provide a method and apparatus for carrying out closed reduction of fractures in long bones and stimulating the enchondral osteogenesis reaction by manipulating the biochemical milieu around the fracture, while diminishing the pain associated with the fracture.
A further object of the present invention is to provide an orthopaedic device which, during the first stage of the enchondral osteogenesis reaction, maintains occlusion of the torn blood vessels at the site of the fracture, and by locally increasing the free calcium ion concentration, can accelerate the intrinsic and extrinsic systems of the known coagulation reactions of clot formation.
It is a further object of the present invention to provide such a method and apparatus which, in addition to applying three-point fixation to fractures in long bones, also compresses and deforms the soft-tissues in proximity with the fracture site so as to intentionally inhibit the microcirculation of blood flow in proximity with the fracture site, thereby creating a biochemical milieu which stimulates the enchondral osteogenesis reaction and diminishes the excitability of the free pain nerve endings.
It is a further object of the present invention to provide apparatus for carrying out such a method, in which a biomechanical advantage is provided by the apparatus in order to efficiently achieve restriction in venous and/or arterial microcirculation of the soft-tissues adjacent the fracture.
It is a further object of the present invention to provide such apparatus which is capable of applying in multiple coordinate planes, three-point fixation of pressure to fractures in long bones which are angulated in a particular oblique coordinate plane.
It is a further object of the present invention to provide such apparatus which is capable of easy adjustment in the location of three-point fixation, and the degree of deformation of soft-tissue required during the healing process.
A further object of the present invention is to provide such an orthopaedic device for a fractured femur or humerus which provides immediate pain relief by diminishing the excitability of the free pain nerve endings and a stabilizing effect which gives the patient confidence to allow him to move the fractured extremity about and exercise the same within the first few days after the fracture.
An even further object of the present invention is to provide a method of reducing the angulation of a fracture in a long bone such as the femur or humerus using principles of biomechanical feedback.
An even further object of the present invention is to provide an orthopaedic device capable of providing the most appropriate bracing contour for embracing a fractured long bone so as to maximally control the alignment of the fracture and therewhile stimulate its healing.
Other and further objects of the present invention will be explained hereinafter, and will be more particularly delineated in the appended claims, and other objects of the present invention will be apparent to one with ordinary skill in the art to which the present invention pertains.